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Dental implant suprastructure device, permanent - ARTG 308834

Access comprehensive regulatory information for Dental implant suprastructure device, permanent in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 308834 and sponsored by Race Dental Pty Ltd, manufactured by Avinent Implant System SLU in Spain. The device registration started on August 30, 2018.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIa
ARTG 308834
Class IIa
Dental implant suprastructure device, permanent
ARTG ID: 308834
Good Name: Race Dental Pty Ltd - Dental implant suprastructure device, permanent
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Intended Purpose

Dental abutments placed into a dental implant to provide support for dental prosthetic restorations. The abutments include: - Titanium Bases to be attached to the underlying implant and upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutment; - Titanium Abutment Blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; - Abutment Screws to permanently fix the abutments to the underlying implant. Abutments are intended for use to support single-tooth (unit) and multiple-tooth (bridges and bars) prostheses, in the mandible or maxilla for functional and aesthetic restorations.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
308834
Start Date
August 30, 2018
Effective Date
August 30, 2018
Manufacturer
Country
Spain
Address
Poligon Industrial Santa Anna 1, Santpedor, 08251